Full Time 40 hours Grade 077 Neuro-Ctr Health & Tech/CMSU Schedule 8 AM-5 PM; OCC WKENDS Responsibilities General Purpose: The incumbent in the Laboratory Technician III position will be expected to possess a basic understanding of the current Good Manufacturing Practices (cGMP) requirements and apply those to the processing of clinical trials supplies within the Clinical Materials Services Unit (CMSU). Provide quality, timely, and consistent clinical trial drug and device packaging in strict compliance to Good Manufacturing Practices (GMPs). Organize and maintain a GMP compliant storage and processing area within the CMSU facility. Determine departmental needs and order all packaging components critical to the assembly of finished study drug/device kits/packages from approved vendors. Organize and maintain a GMP compliant storage facility. Maintain a GMP compliant system for the accounting of and return of investigational products. Generate, organize, and maintain documents in compliance with requirements of cGMPs. Handle drugs, devices, and components in accordance with cGMPs during receipt, warehousing, processing, distributions, return, and destruction. Responsibilities: Processing Operations: To follow GMPs and high quality standards in the labeling, packaging, and distribution of clinical materials in accordance with written procedures. Must have thorough understanding of the relation of the required labeling to the overall study design. Foster an environment of continuous improvement by remaining alert to opportunities for improvement and offering suggestions. Inventory Control: Anticipate departmental needs based on establish clinical plans for the ordering of all packaging components critical to the assembly of finishing study supplies. Make necessary adjustments to computer-based inventories to reflect accurate stock levels. Master and utilize the various capabilities of the clinical software in meeting the challenge of providing compliant labels in a timely fashion and cross train other appropriate Clinical Materials Services Unit (CMSU) personnel in the use of the labeling system. Document Management: Must accurately execute and file all documentation generated in routine departmental operations. Must constantly review the necessity and effectiveness of existing forms and recommend appropriate changes, additions, and deletions. Facility Operations: Organize and maintain a GMP compliant facility. Ship, receive, and keep accurate records, and routinely clean processing rooms, drug/device and component storage areas. Qualifications: Associate's degree in appropriate discipline plus 2-3 years specialized experience in related field; or equivalent combination of education and experience. Minimum of two years of pharmaceutical industry experience and/or clinical trial supply experience, working knowledge of GMPs along with computer skills (e.g. Microsoft Word and Excel), and excellent oral and written communication skills. Ability to work well in a team environment where all work product is reviewed and approved by the Quality Assurance group before any work product leaves CMSU.

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